This invention relates generally to a system and method for introducing medical devices into vasculature. In particular, the present invention is concerned with the parallel introduction of a second guidewire into vasculature of the body, into which one guidewire has already been introduced, in such a way as to prevent entanglement of the guidewires. The present invention is also directed to facilitating removal of a dilator from vasculature without having to retract it the entire guidewire length. As used herein, the term “proximal” refers to a location on the device closest to the clinician using the device. Conversely, the term “distal” refers to a location on the device farthest from the clinician and closest to the patient into whom the device is to be inserted.
For many medical purposes it is important to introduce devices, both permanently and for temporary diagnostic purposes, through the skin and underlying tissue layers into blood vessels or other locations inside the body of a patient. One of the earliest methods used to place such devices into the body involved cutting an opening in the body, inserting the device and then either closing the wound around the device or after the device has been removed. Because of the high skill and specialized medical facilities required to accomplish such a procedure, as well as the risk of trauma and infection, a need arose to develop less-invasive methods.
It is well established that percutaneous methods, involving creating a small opening in tissue and the use of devices such as dilators to gain access to vasculature, allow for the introduction of medical devices into the body without some of the risks associated with earlier methods. In particular, the size of the cut down employed to gain access to a vessel could be minimized. However, the use of a dilator alone requires that the medical device be inserted quickly once the dilator is removed. Additionally, such systems can also have associated therewith the risk of bleeding, damage to the medical device, or damage to the body during insertion.
It has also been established that the use of a thin-walled peel-away introducer sheath secured to a dilator at its proximal end provides for the introduction of medical devices while reducing some of the risks associated with dilator-only systems. The peel-away sheath allows removal of the dilator while leaving the sheath inside the body, thereby maintaining access to the expanded tissue opening and providing a conduit for the medical device. Additionally, such systems can reduce the tendency of the dilator to migrate proximally when it is initially introduced through the skin and subcutaneous tissue.
One drawback of conventional introducer devices becomes apparent when more than one guidewire is required for a particular procedure. When more than one guidewire is introduced into a single vessel, there is a possibility that they may become entangled. Another drawback of present devices is that removal of the dilator requires it to be retracted along the entire guidewire.
Accordingly, there is a need for a device and method that facilitates the insertion of more than one guidewire into vasculature while avoiding the potential for entanglement as well as permits a dilator to be removed without having to retract it along the entire guidewire length. The present invention fulfills these and other needs.